MAUDE Adverse Event Report: MIDMARK CORP. RITTER; 355 LIGHT SYS

Model Number 355-028

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2014

Event Type  malfunction  

Event Description

Midmark was notified that a light fell from the ceiling mount while a patient was in the room.No injuries sustained.

Manufacturer Narrative

The unit was returned and is currently being assessed.Additional relevant information will be shared when the investigation report becomes available.

• Brand Name: RITTER
• Type of Device: 355 LIGHT SYS
• Manufacturer (Section D): MIDMARK CORP.; versailles OH
• Manufacturer Contact: jane carroll ; 60 vista dr.; p.o. box 286; versailles, OH 45380 ; 9375268604
• MDR Report Key: 4755259
• MDR Text Key: 5890452
• Report Number: 1523530-2015-00003
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 355-028
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2015
• Date Manufacturer Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other